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5-ASA Derivative

Zoenasa vs Mesalamine Enema for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Altheus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects aged between 18 and 64 years
Male subjects must meet specific contraceptive requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is designed to study the safety and efficacy of Zoenasa Rectal Gel, compared to mesalamine enema, in subjects with left-sided ulcerative colitis.

Who is the study for?
Adults aged 18-64 with left-sided ulcerative colitis and mild to moderate disease activity can join. They must have stable liver function tests, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with severe diseases, recent mesalamine or steroid use, history of certain cancers or drug abuse, allergy to trial drugs, or inability to retain enemas.Check my eligibility
What is being tested?
The study compares Zoenasa Rectal Gel (a combination of N-acetylcysteine and mesalamine) against a standard mesalamine enema in treating left-sided ulcerative colitis over six weeks. Participants will be randomly assigned to one of the two treatments in equal numbers for comparison.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to the rectal administration of medication and possible allergic reactions if sensitive to ingredients like N-acetylcysteine or mesalamine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.
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I am following the required contraceptive measures.
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I have a history of ulcerative colitis affecting the left side of my colon, and it's currently mild to moderate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in modified UCDAI at 6 weeks
Secondary outcome measures
Change from baseline in endoscopic appearance after 3 weeks
Change from baseline in endoscopic appearance after 6 weeks
Change in modified UCDAI at 3 weeks
+8 more

Side effects data

From 2012 Phase 4 trial • 33 Patients • NCT01090102
3%
Liver Cirrhosis
3%
Death
3%
Drug relapse
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesalamine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Zoenasa-1:4Experimental Treatment1 Intervention
Group II: Mesalamine EnemaActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Altheus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
9 Patients Enrolled for Ulcerative Colitis

Media Library

Mesalamine Enema (5-ASA Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT01586533 — Phase 2
Mesalamine Enema (5-ASA Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01586533 — Phase 2
Ulcerative Colitis Research Study Groups: Mesalamine Enema, Zoenasa-1:4
Ulcerative Colitis Clinical Trial 2023: Mesalamine Enema Highlights & Side Effects. Trial Name: NCT01586533 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient pool of this trial inclusive to those aged eighty and beyond?

"This trial is open to those between 18 and 64 years old. Clinicaltrials.gov also lists 72 trials targeting patients under the age of majority, with 353 studies specifically for individuals 65 or older."

Answered by AI

How many participants have been enrolled in this trial thus far?

"This clinical trial is currently not seeking patients, as the last edit was made in January 2014. Alternatively, 408 trials for ulcer are presently recruiting and 10 studies related to Zoenasa-1:4 have open enrolment opportunities."

Answered by AI

Is this research a pioneering endeavor?

"Currently, 10 distinct trials of Zoenasa-1:4 are in progress across 48 cities and 7 nations. Altheus Therapeutics, Inc.'s 2012 trial was the first to initiate research on this drug; it underwent Phase 2 approval with 120 patients involved. Since then, 90 additional experiments have been concluded."

Answered by AI

At what venues can patients access this trial?

"45 sites are currently participating in this trial, ranging from Dothan to Chesterfield and Winter Park. For the sake of convenience, it is best to select a clinic close to you if you choose to become enrolled."

Answered by AI

Could you elucidate any other experiments conducted involving Zoenasa-1:4?

"The initial clinical trial using Zoenasa-1:4 was conducted in 2012 at Houston Digestive Disease Clinic. Since then, 90 completed studies have been reported, and 10 are still ongoing with a major hub for research located in Dothan, Alabama."

Answered by AI

Has the FDA authorized Zoenasa-1:4 for consumption?

"Due to the nature of being a Phase 2 trial, with some safety data but none for efficacy, Zoenasa-1:4 received a score of two on our team's assessment scale."

Answered by AI

Are investigators still enrolling participants for this investigation?

"Perusal of clinicaltrials.gov shows that the initial posting for this experiment was on June 1st 2012 and most recently updated January 7th 2014 - it is not actively recruiting at present, yet there are 418 other trials available to join."

Answered by AI

Is it possible to join the experiment?

"This trial is currently seeking 120 individuals aged 18 to 64, who suffer from ulcerative colitis. To be eligible for the study, they must have a documented history of idiopathic UC with mild-to-moderate active disease and fulfill other criteria such as modified UCDAI score 4 - 10 (inclusive), Physician's rating of 2 points or less, rectal bleeding 1 point or more (subject diary) and mucosal appearance based on endoscopy at least 1 point."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
LeBauer Research Associates, P.A.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
2012. "Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01586533.
All > Inflammatory Bowel Disease > Colitis
~9 spots leftby Apr 2025
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